Kornimate/medical-research-clean huggingface dataset:
one year clinical evaluation of new gradient technology monolithic zirconia (5y-tzp/3y-tzp) crowns in dental esthetic zone with vertical versus conventional preparation techniques

Conditions: Single Anterior Crowns; Badly Decayed Teeth; Endodontically Treated Teeth; Spacing Between Anterior Teeth; Malposed Teeth(Tilted,Overerupted,Totated,Etc.)

Summary: the aim of this study is to evaluate the clinical behavior of zirconia crowns in dental esthetic zone with vertical versus conventional preparation techniques using a new gradient technology monolithic zirconia (5y-tzp/3y-tzp).

introduction: a good relationship between dental restorations and the periodontium is one of the most important aspects to ensure clinical success both in terms of esthetics and function. dental preparation for fixed prostheses can take various forms classified as horizontal preparation with a defined margin (chamfer), or vertical, or without a margin/finish line. according to some clinical reports, vertical preparation technique provides an increases in the gingival thickness and a greater stability of the gingival margin. moreover, vertical preparation is characterized by being more conservative with tooth structure. also, taking impressions is easier since it is a finish area and not a defined line. null hypothesis: 1. there will be no difference between vertical and conventional preparations in the clinical behavior of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation. 2. there will be no difference between vertical and conventional preparations in the patient satisfaction of zirconia crowns in dental esthetic zone at baseline,3,6,9,12 months evaluation.

Eligibility criteria:
inclusion criteria: 1. from 21-50 years old, be able to read and sign the informed consent document. 2. have no active periodontal or pulpal diseases, have teeth with good restorations. 3. psychologically and physically able to withstand conventional dental procedures. 4. patients with teeth problems indicated for all ceramic crowns in esthetic zone; 1. badly decayed teeth 2. teeth restored with large filling restorations 3. endodontically treated teeth 4. malformed teeth 5. malposed teeth (tilted, over-erupted, rotated, etc.) 5. able to return for follow-up examinations and evaluation. 6. thick gingival biotype. exclusion criteria: 1. patient less than 21or more than 50 years. 2. patient with active resistant periodontal diseases. 3. patients with poor oral hygiene and uncooperative patients. 4. pregnant women. 5. patients in the growth stage with partially erupted teeth. 6. psychiatric problems or unrealistic expectations. 7. patient with periodontal problems. 8. patients with malocclusion or parafunctional habits.
rehabilitative trial with cerebello-spinal tdcs in neurodegenerative ataxia

Conditions: Ataxia, Cerebellar; Cerebellar Ataxia; Spinocerebellar Ataxias; Ataxia, Spinocerebellar; Spinocerebellar Ataxia Type 1; Spinocerebellar Ataxia Type 2; Spinocerebellar Ataxia 3; Spinocerebellar Degenerations; Friedreich Ataxia; Ataxia With Oculomotor Apraxia; Multiple System Atrophy

Summary: neurodegenerative cerebellar ataxias represent a group of disabling disorders for which we currently lack effective therapies. cerebellar transcranial direct current stimulation (tdcs) is a non-invasive technique, which has been demonstrated to modulate cerebellar excitability and improve symptoms in patients with cerebellar ataxias. in this randomized, double-blind, sham-controlled study, the investigators will evaluate whether a two-weeks' treatment with cerebellar anodal tdcs and spinal cathodal tdcs can improve symptoms in patients with neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short and long term.

neurodegenerative cerebellar ataxias represent a heterogeneous group of disabling disorders in which progressive ataxia of gait, limb dysmetria, oculomotor deficits, dysarthria and kinetic tremor are the prominent clinical manifestations. both the hereditary and sporadic forms usually present in young adulthood, and are characterized by atrophy of cerebellar or brainstem structures. currently, cerebellar ataxia lack effective disease-modifying therapies. cerebellar transcranial direct current stimulation (tdcs) is a non-invasive technique, which has been demonstrated to modulate cerebellar excitability and improve symptoms in patients with cerebellar ataxias. the present randomized, double-blind, sham-controlled study will investigate whether a two-weeks' treatment with cerebellar anodal tdcs and spinal cathodal tdcs can improve symptoms in patients with neurodegenerative cerebellar ataxia and can modulate cerebello-motor connectivity, at short and long term. subjects will be randomized in two groups, one receiving a 10 day (5 days/week for 2 weeks) treatment with anodal cerebellar and cathodal spinal tdcs and the other receiving sham stimulation with identical parameters. after the intervention, patients will be reassessed with a clinical and neurophysiological evaluation at 2 weeks, 1 months and 3 month after treatment.

Eligibility criteria:
inclusion criteria: * patients with a cerebellar syndrome and quantifiable cerebellar atrophy exclusion criteria: * severe head trauma in the past * history of seizures * history of ischemic stroke or hemorrhage * pacemaker * metal implants in the head/neck region * severe comorbidity * intake of illegal drugs * pregnancy

Keywords: transcranial direct current stimulation transcranial magnetic stimulation spinocerebellar ataxia cerebellar ataxia
assessment of radiolabeled rhannexin v-128 in infective endocarditis

Conditions: Endocarditis; Thrombosis

Summary: intraluminal thrombi adherent to cardiac valves or atria share a common pathophysiology involving the aggregation of activated platelets with phosphatidylserine (ps) expression on the outer layer of the thrombus. they also share common complications, i.e. damages to the underlying myocardium and embolic risk related to thrombus fragmentation. the diagnostic work-up, currently relying on morphologic imaging alone (mainly echography), lacks sensitivity and does not allow to differentiate between active (renewal and growth activity) and quiescent (scarred) thrombus. it is therefore highly desirable to develop a new approach able to non-invasively provide insight on the biological activity of thrombi and to detect embolic events in a single exam. annexin v is a 36 kda endogenous glycoprotein which binds ps with nanomolar affinity. radiolabeled annexin v has been shown to provide molecular imaging of ps expressed by apoptotic cells or activated platelets. the ability of the imaging agent to bind mural thrombus has been established in vivo in a murine model of abdominal aortic aneurysm and ex vivo in human. it has been also shown that radiolabeled annexin v allowed in vivo detection of vegetations and secondary pulmonary emboli with high sensitivity in various animal models of infective endocarditis. a radiolabeling kit of annexin v complying with gmp requirements has been developed (rhannexine v-128, advanced accelerator applications - atreus) and is currently available. annie is a single centre, proof of concept, interventional, open, non-randomized study aiming at evaluating the sensitivity of 99mtc-annexin v-128 in the detection thrombus in comparison with reference imaging in patients presenting with either: 1/ infective endocarditis or 2/ atrial thrombus. the safety of the 99mtc-annexin v-128 will be assessed in a first phase (10 first patients enrolled). data in relation with safety of the imaging agent will be reviewed by an independent data and safety monitoring board (dsmb); in case of positive answer, the study will continue with a second phase. the data gathered in all patients (n=120) will be used to determine outcome measures.


Eligibility criteria:
inclusion criteria: * stable clinical status * signed informed consent * contraception in women of childhood potential * endocarditis group: * definite ou possible endocarditis (modified duke criteria) * atrial thrombosis group: * presence of atrial thrombosis evidenced by transesophageal echocardiography exclusion criteria: * pregnant or lactating women * contra-indication to both mri and ct * endocarditis group: * history of cardiac surgery in relation with the current episode * (effective) antibiotic regimen for more than 15 days

Keywords: radionuclide imaging annexin
impact of physical activity on biomarker of aging and body composition among breast cancer survivors age 65 and older

Conditions: Breast Cancer; Aging; Physical Activity

Summary: to determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.

lccc1410 is designed to compare the change in p16 from baseline to end of chemotherapy in 100 older (≥ 65 years) breast cancer patients participating in a home-based physical activity program (intervention group) to 100 patients in the concurrent control group not participating in a physical activity intervention (enrolled in a separate ro1 study as described in section 1.7). the biomarker p16 is known to dramatically increase with chemotherapy, and we hypothesize that the increase will be attenuated by a physical activity intervention. we will evaluate changes in p16 between the two study populations. data from the geriatric assessment at baseline will be used to characterize the study population, and subscale scores from the ga will also be assessed for differences between baseline and end of chemotherapy to compare the lccc1410 study population with the concurrent control.

Eligibility criteria:
inclusion criteria: * age 65 or older, female * histologically confirmed stage i, ii or iii breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis) * scheduled to begin an appropriate adjuvant or neoadjuvant chemotherapy regimen as defined by nccn guidelines (www.nccn.org) * english speaking * irb approved, signed written informed consent * approval from their treating physician to engage in moderate-intensity physical activity * patient-assessed ability to walk and engage in moderate physical activity * willing and able to meet all study requirements. exclusion criteria: - one or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.

Keywords: cancer breast cancer geriatric advance age exercise physical activity genetic marker p16 chemotherapy breast cancer treatment
transplantation of autologous rpe versus translocation of autologous rpe and choroid in amd

Conditions: Age-Related Macular Degeneration

Summary: the purpose of this study is to evaluate two surgical interventions in patients with amd.

the submacular surgical trials have shown that submacular membrane extraction alone did not improve or preserve visual acuity in patients with amd. transplantation of autologous rpe and translocation of autologous rpe and choroid represent two promising therapeutic interventions in patients with amd. this prospective, randomized clinical trial compares the two surgical treatments and additionally compares the clinical results (visual acuity, fla) with oct- and uhr-oct data.

Eligibility criteria:
inclusion criteria: * amd and submacular cnv * non responders to laser treatment or pdt * treatment: rpe transplantation or rpe + choroid translocation * age over 50 years exclusion criteria: * other additional retinal diseases, like diabetic or hypertensive retinopathy and vascular diseases. * optic atrophy * unstable glaucoma

Keywords: submacular membrane transplantation of rpe translocation of rpe and choroid
clinical study of the whitening dentifrices on tooth color and sensitivity

Conditions: Dentin Hypersensitivity

Summary: objective:the aim of this clinical study was to evaluate tooth color alteration (δe) and tooth sensitivity (ts) in patients that used two commercial brand-whitening dentifrices for four weeks. sixty participants were selected in accordance with inclusion and exclusion criteria and randomly allocated in three groups (n=20): g1-colgate luminous white®, g2- close up white now® and g3- sorriso® dentifrice (placebo). then, participants received the instructions to use only the blinded supplied dentifrice and toothbrush to make the habitual oral hygiene, three times per day during four weeks. evaluators assessed tooth color (ciel\*a\*b system) and ts (vas scale) at baseline and every week (assessment points 1, 2, 3 and 4). two-way anova and posterior tukey and friedman test analyzed data (α = 0.05).


Eligibility criteria:
inclusion criteria: * at least six anterior teeth without restorations * participants should have good general and oral health (no dental caries and periodontal disease) exclusion criteria: * tooth sensitivity * any condition that could cause tooth sensitivity (non-carious cervical lesions, dentin exposure) * participants following orthodontic treatment * smokers

Keywords: whitening dentifrices color alteration tooth sensitivity
an efficacy study of morab-009 in subjects with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to investigate the activity of morab-009 when added to a standard regimen of gemcitabine in patients with previously untreated unresectable stage 3 or 4 pancreatic cancer.


Eligibility criteria:
inclusion criteria: 1. female or male subjects, ≥ 18 years of age, with cytologically or histologically confirmed diagnosis of pancreatic adenocarcinoma. 2. must have measurable disease, as defined by recist or evaluable by clinical signs/symptoms (e.g. ascites, pleural effusion, or lesions of less than 2 cm) supported by biomarker, radiologic, or pathologic studies conducted within 4 weeks prior to study entry. 3. must have unresectable disease and have received no prior chemotherapy or radiation therapy for their pancreatic cancer. 4. karnofsky performance status of greater than or equal to 70 %. 5. female subjects of childbearing potential and all male subjects must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period. 6. other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to study day 1. 7. laboratory and clinical results within the 2 weeks prior to study day 1 as follows: absolute neutrophil count (anc) ≥ 1.5 x 109/l platelet count ≥ 100 x 109/l hemoglobin ≥ 9 g/dl serum bilirubin ≤ 2.0 mg/dl aspartate transaminase (ast)\* ≤ 5 x upper limit of normal (uln) alanine transaminase (alt)\* ≤ 5 x uln alkaline phosphatase\* ≤ 5 x uln serum creatinine ≤ 2.0 mg/dl stenting to reduce liver functions to qualifying levels is permitted. \* subjects with liver function abnormalities greater than the uln are eligible only if in the opinion of the investigator they are due to disease obstruction of the bile ducts or metastatic disease. 8. must be willing and able to provide written informed consent. exclusion criteria: 1. known central nervous system (cns) tumor involvement. 2. evidence of other active malignancy requiring treatment. 3. clinically significant heart disease (e.g., congestive heart failure of new york heart association class 3 or 4 angina not well controlled by medication, or myocardial infarction within 6 months). 4. electrocardiogram (ecg) demonstrating clinically significant arrhythmias (note: subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia \[svt\], are eligible). 5. active serious systemic disease, including active bacterial or fungal infection. 6. active viral hepatitis or symptomatic human immunodeficiency virus (hiv) infection. 7. prior chemotherapy or radiation therapy for their pancreatic cancer. 8. breast-feeding, pregnant, or likely to become pregnant during the study. 9. no other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids with the exception that low-dose corticosteroids are allowed) 10. known hypersensitivity to a monoclonal antibody or biologic therapy.
the prediction model of avastin plus chemotherapy in unresectable ras mutant crlm patients

Conditions: Colorectal Cancer; Liver Metastases

Summary: establishment and validation of the prediction model of avastin plus chemotherapy as first line treatment in simultaneous ras mutant unresectable crlm patients

ras mutant unresectable crlm patients with primary tumor resection followed by avastin in combination with chemotherapy were included in this study. the tumor response was assessed by local mdt group. based on tumor response, 58 crlm patients were classified into two groups (cr+pr vs sd+pd). primary samples of the two group patients will be sequenced by mass spectrum. after ms sequencing, a prediction model will be estimated. another 58 crlm patients will be inclued for validation of the prediction model.

Eligibility criteria:
inclusion criteria: age 18-75 years, histologically proven colorectal adenocarcinoma, with liver-dominant disease, a life expectancy of \> 3 months, ras mutation, unresectable simultaneous liver metastasis, ecog 0-1, written informed consent for participation in the trial. exclusion criteria: patients with known hypersensitivity reactions to any of the components of the study treatments, pregnancy or breast-feeding, accepted chemotherapy, radiotherapy and target therapy before primary tumor resection, other previous malignancy within 5 years, known drug abuse/alcohol abuse, ecog\>1, legal incapacity or limited legal capacity.
dosage study for vigamox eye drops prior to intravitreal injections

Conditions: Intravitreal Injection Patients

Summary: antibiotic eye drops are being used before and after intravitreal injections. currently there is no study indicating the benefit of there usage or their dosage. in this study we compare the efficacy of vigamox eye drops (antibiotic)starting 3 days prior to the injection versus 1 day prior to intravitreal injection.


Eligibility criteria:
inclusion criteria: * patient who need intravitreal injections patients who are willing to participate in the study exclusion criteria: * patients who are allergic to vigamox or who have taken any eye drops within the past 3 weeks

Keywords: vigamox, topical antibiotics, intravitreal injections, macular degeneration, endophthalmitis
a proms based educational tool (prom-da) for patients considering total knee arthroplasty

Conditions: Knee Osteoarthritis; Total Knee Arthroplasty

Summary: the primary objectives of this study are to: 1) develop an educational tool known as the patient reported outcome measure informed decision aid (prom-da) that will describe the options for patients considering total knee arthroplasty (tka) surgery, and help them imagine what to expect if they choose either option; 2) assess the extent that the prom-da improves patients decision quality; 3) determine the feasibility of a larger trial to test the prom-da in multiple sites and more patients.


Eligibility criteria:
inclusion criteria: * adult (age≥30) patients with knee osteoarthritis (oa) * have an appointment with a surgeon for consultation about total knee arthroplasty at the edmonton bone and joint centre * understands, speaks and reads english; and * able to provide informed consent. exclusion criteria: * individuals who have had prior total knee arthroplasty * physician-diagnosed rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, fibromyalgia, or gout.
distribution of secukinumab (ain457) into dermal interstitial fluid after a single subcutaneous administration of 300 mg

Conditions: Healthy; Psoriasis

Summary: the proposed exploratory study aims to understand the in vivo skin distribution properties of subcutaneously (s.c.) administered ain457 in psoriatic and healthy skin using open flow microperfusion (ofm). the data of this study will help to understand the mode of action of ain457 in its target tissue. it aims to establish a technique assessing in vivo distribution of ain457 and its metabolites in human dermal interstitial fluid (isf) and exploring a potential pharmacodynamic effect in situ. in addition, the study will further evaluate safety and local tolerability of subcutaneously administered ain457 and explore dermal interstitial fluid skin levels of potential disease relevant biomarkers. the study is divided into two parts - part i with 8 healthy volunteers (hv) to validate the method is completed and part ii with 8 psoriasis patients will start based on the outcome of part i.


Eligibility criteria:
for part i : healthy male and female subjects 18 to 65 years of age inclusive; for part ii: chronic plaque-type psoriasis (with or without arthritis) diagnosed for at least 6 months before enrollment including at least one plaque accessible for ofm with at least moderate severity ; key exclusion criteria for part i and part ii: women of child-bearing potential unwilling to use effective contraception; history of an ongoing, chronic or recurrent infectious disease, or evidence of tuberculosis infection as defined by a positive tb-test at screening; for part i: use of any prescription drugs, herbal supplements, within 4 weeks prior to initial dosing for part ii: ongoing use of concomitant psoriasis treatments. washout periods have to be adhered to. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: psoriasis interstitial fluid open flow microperfusion il-17 inflammatory skin disease scaly patches healthy volunteers and psoriasis patients
comparison of procedural sequences in same-day painless bidirectional endoscopy with colonoscopic water exchange method

Conditions: Colon Disease; Bidirectional Endoscopy

Summary: this prospective randomized controlled trial is to compare evaluate the optimal procedure sequence among patients undergoing water exchange colonoscopy.

same-day esophagogastroduodenoscopy (egd) and colonoscopy (bidirectional endoscopy; bde) are commonly performed to evaluate for gastrointestinal conditions, such as active gastrointestinal bleeding, iron deficiency anemia, positive fecal occult blood tests and abdominal pain. egd-colonoscopy sequence seems to be the reasonable choice for bde using air or co2. with the use of water exchange method, endoscopists have to remove the dirty fecal material and air bubble during insertion. gas insufflated during egd may get into the colon and make subsequent water exchange colonoscopy more difficult. the aim of this prospective randomized controlled trial is to compare evaluate the optimal procedure sequence among patients undergoing water exchange colonoscopy.

Eligibility criteria:
inclusion criteria: * patients underwent fully sedated bidirectional endoscopy in the physical check-up department exclusion criteria: * patients who \ 80 years old * without standard colon preparation * allergy to meperidine or propofol * with a history of partial colectomy * refusal to provide written informed consent * american society of anesthesiology (asa) risk class 3 or higher

Keywords: water exchange colonoscopy cecal insertion time bidirectional endoscopy